U.S. patent number 4,782,946 [Application Number 07/097,868] was granted by the patent office on 1988-11-08 for soft contact lens hydration device and kit.
This patent grant is currently assigned to Allergan, Inc.. Invention is credited to Martin M. Pollak.
United States Patent |
4,782,946 |
Pollak |
November 8, 1988 |
Soft contact lens hydration device and kit
Abstract
A hydration device and kit are provided for effecting the
hydration of a dehydrated soft contact lens resident within the
cavity of a mold element in which the lens was formed.
Inventors: |
Pollak; Martin M. (Laurel
Hollow, NY) |
Assignee: |
Allergan, Inc. (Irvine,
CA)
|
Family
ID: |
22265518 |
Appl.
No.: |
07/097,868 |
Filed: |
September 17, 1987 |
Current U.S.
Class: |
206/223; 134/901;
206/5.1; 206/523; 264/2.6; 425/808 |
Current CPC
Class: |
A45C
11/005 (20130101); Y10S 425/808 (20130101); Y10S
134/901 (20130101) |
Current International
Class: |
A45C
11/00 (20060101); A45C 001/04 (); B65D
085/30 () |
Field of
Search: |
;206/523,223,5.1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Price; William
Attorney, Agent or Firm: Skoler; George A. Pirri; Vincent P.
Kanagy; James
Claims
What is claimed is:
1. A hydration device comprising an enclosure possessing means for
permitting contact of a dehydrated contact lens in resident
association with a mold element in which the lens was formed with
hydration liquid, said device containing at least one such combined
lens/mold element assembly.
2. The hydration device of claim 1 wherein the enclosure is defined
by upper and lower interengaging members either or both of which
possess one or more passages for admitting hydration liquid
therein.
3. The hydration device of claim 1 wherein the dehydrated contact
lens is resident within the cavity of a mold element employed in a
centrifugal lens casting procedure.
4. A kit for effecting the hydration of a dehydrated contact lens
and the separation of the lens from the cavity of a mold element in
which the lens was formed which comprises:
(a) at least one lens hydration device possessing an enclosure
capable of containing at least one dehydrated contact lens in
resident association with the cavity of a mold element in which the
lens was formed, said device possessing means for permitting
contact of said lens with hydration liquid;
(b) at least one dehydrated contact lens in resident association
with the cavity of a mold element in which the lens was formed;
and,
(c) a quantity of hydration liquid.
5. The kit of claim 4 wherein the dehydrated contact lens is
resident within the cavity of a mold element employed in a
centrifugal lens casting procedure.
6. The kit of claim 4 wherein the enclosure of the hydration device
is defined by upper and lower interengaging members either or both
of which possess one or more passages for admitting hydration
liquid therein.
7. The kit of claim 4 wherein a plurality of such combined
dehydrated lens/mold element assemblies and hydration devices are
provided.
8. The kit of claim 7 wherein the combined dehydrated lens/mold
element assemblies are stored within a tubular container.
9. The kit of claim 7 wherein one or more combined dehydrated
lens/mold element assemblies are packaged in a packet.
10. The kit of claim 7 wherein one or more combined dehydrated
lens/mold element assemblies are packaged in individually separable
packets formed as part of a sheet or strip of said packets.
11. The kit of claim 7 wherein at least a portion of an exterior
surface of the hydration devices is capable of receiving
lens-identifying indicia applied thereto.
12. The kit of claim 4 further comprising one or more vessels for
holding hydration liquid and/or other lens treating
composition(s).
13. The kit of claim 4 further comprising means for gripping the
contact lens.
14. The kit of claim 13 wherein the gripping means is a set of
soft-tipped tweezers.
15. The kit of claim 4 comprising at least one additional material
or composition for treating the contact lens.
16. The kit of claim 15 wherein said additional material or
composition is one for cleaning, sterilizing, preserving, storing,
removing peroxide, or performing any combination of the aforesaid
operations.
17. The kit of claim 4 further comprising a packaging unit for
receiving the kit components.
18. The kit of claim 17 wherein the packaging unit is an
impact-absorbing material or construction containing recesses for
the kit components.
19. The kit of claim 18 wherein the impact-absorbing material is a
polyolefin foam or a styrenic polymer foam.
Description
This invention relates to the field of soft contact lenses, i.e.,
those formed from hydrogels, and receptacles therefor. More
particularly, the present invention is directed to a dehydrated
contact lens in resident association with the cavity of a mold
member in which the lens was formed and a hydration device for the
dehydrated lens/mold member combination, optionally provided as
part of a kit for hydrating the lens and rendering it suitable for
wearing.
The term "hydrogel" is descriptive of any water absorptive,
optically clear material which is suitable for the fabrication of a
contact lens. Illustrative of such materials are the water
swellable, water-insoluble shape-retaining polymers disclosed,
inter alia, in U.S. Pat. Nos. 2,976,576, 3,220,960 and 3,822,089.
These and related polymers are prepared from liquid polymerizable
reaction mixtures containing monomer(s), initiator, catalyst, etc.
Upon undergoing polymerization, the mixtures provide sparingly
cross-linked water-absorptive polymeric hydrogels. In the hydrated
sate, contact lenses formed from such hydrogels are soft and
pliable, have high oxygen permeability and as such are relatively
comfortable to wear.
Contact lenses can be fabricated employing any of several known and
conventional methods. The lenses can be machined, or lathed, to
specification from a plastic lens blank. This is a fairly labor-
and skill-intensive technique. Soft contact lenses can also be
manufactured by various molding techniques which offer obvious
advantages of economy. In one method, a plastic lens is cast molded
in a static mold (see, for example, U.S. Pat. No. 4,121,896 for a
male-female mold assembly which can be used in such a method). In
another type of molding method, a plastic lens is formed in a
rotating mold (see, for example, the centrifugal lens casting
apparatus, molds and procedures described in U.S. Pat. Nos.
4,517,138, 4,517,139, 4,517,140 and 4,568,501).
Whatever the fabrication technique used, the contact lens must
undergo one or more post-lens forming operations to prepare it for
wearing. Thus, the lens is washed, generally several times, with a
hydrating liquid such as physiological saline (0.09 wt. % saline)
in order to leach, or extract, any residual unreacted material,
e.g., monomer(s), initiator, catalyst, etc., and at the same time
swell the lens and render it compatible with the fluids of the eye.
Where a lens has been formed by molding, the dehydrated lens, still
resident within a mold member used in forming the lens, is
introduced into a quantity of hydrating liquid, e.g., physiological
saline as just mentioned, which causes the lens to swell and
separate from the mold member. Thereafter, the lens is washed,
visually inspected, sterilized, packaged, e.g., in a
rubber-stoppered glass vial sealed with a metal crimp (usually one
of aluminum), and the package is labeled. These post-lens forming
operations are carried out at the lens manufacturing site and
account for a significant percentage of the cost of a molded
contact lens.
In recent years, accumulated medical evidence has strongly pointed
to the considerable benefits to eye health to be gained by
replacing contact lenses on a fairly frequent and regular basis.
Lens care regimens involving surfactants and/or enzymatic protein
removal procedures are at best only moderately successful in
maintaining lenses in an optimum state of cleanliness. Even this
degree of lens maintenance becomes greatly compromised when the
wearer fails to adhere to the proper regimen.
Dirty lenses contribute to visual and physiological problems. This
is especially true with extended wear lenses because wearers often
are unaware of a problem with a dirty lens and may continue to wear
a lens despite its having accumulated excessive dirt and
proteinaceous debris.
Considerations of economy aside, the ideal answer to this problem
would be to provide the contact lens wearer with the capability for
disposing the lenses on a frequent scheduled basis and replacing
them with new, clean factory fresh lenses. This approach has
already been promoted in various forms by contact lens suppliers.
Thus, in one case, patients are dispensed several sets of lens in
conventional sterile glass vials, such as those described above,
which are normally used to store and ship lenses to practitioners.
The high cost of the post-lens forming operations previously
referred to tends to make such frequent replacement of lenses
prohibitively expensive thereby discouraging the implementation of
what is otherwise a sound and beneficial opthalmic practice.
U.S. Pat. No. 4,429,786 describes an integrated contact lens
maintenance kit and carrying apparatus for the storage and carrying
of a user's contact lenses as well as a plurality of liquids
normally utilized with such lenses. U.S. Pat. No. 4,568,517
describes a kit for disinfecting lenses with a hydrogen peroxide
solution and for neutralizing the hydrogen peroxide solution. The
kit comprises means for washing the lens and a tablet or
particulate neutralizer. No mention is made in either of these
patents of hydrating a molded dehydrated soft contact lens resident
within the cavity of a mold element or of separating the lens from
the mold.
It is an object of the present invention to provide a device for
facilitating the hydration of a molded soft contact lens resident
in the cavity of a mold element in which the lens was formed, the
separation of the lens from the mold and, optionally, one or more
additional post-lens forming treatments such as extraction of
residual material(s), disinfection, cleaning, and the like.
Another object of the invention is to provide a disposable kit for
effecting hydration of a dehydrated molded soft contact lens
residing within the cavity of a mold element in which the lens was
formed, the kit being primarily intended for use away from the site
at which the lens is manufactured.
It is a particular object of the invention to provide such a
disposable kit together with a quantity of combined dehydrated
lens/mold elements and hydration devices and, optionally, one or
more other components useful in such other post-lens forming
treatments as previously mentioned.
SUMMARY OF THE INVENTION
By way of satisfying these and other objects of the invention,
there is provided a lens hydration device possessing an enclosure
containing at least one dehydrated contact lens in resident
association with the cavity of a mold element in which the lens was
formed, said hydration device possessing means for permitting
contact of the lens with hydration liquid.
The invention further comprises a kit for effecting the hydration
of a dehydrated contact lens and the separation of the lens from
the cavity of a mold element in which the lens was formed, the kit
comprising:
(a) at least one lens hydration device possessing an enclosure
capable of containing at least one dehydrated contact lens in
resident association with the cavity of a mold element in which the
lens was formed, said device possessing means for permitting
contact of said lens with hydration liquid;
(b) at least one dehydrated contact lens in resident association
with the cavity of a mold element in which the lens was formed;
and,
(c) a quantity of hydration liquid.
Use of the lens hydration device and kit of this invention makes it
possible to shift the hydration and demolding operations and,
optionally, other post-lens forming operations, procedures which
contribute appreciably to the cost of factory-finished lenses, from
the lens manufacturing site to the contact lens wearer. Thus, in
avoiding the cost of factory labor associated with some or all of
such post-lens forming operations as hydrating the lens out of the
mold, washing the hydrated lens, sterilizing the lens, packaging
the lens in the sort of bulky glass vials typically used for this
purpose and labeling the lens package, the foregoing lens hydration
device and kit make it economically feasible for a contact lens
wearer to discard worn lenses on a regular and frequent basis.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates in enlarged cross-section, a lens hydration
device containing a dehydrated soft contact lens within the cavity
of a mold element in which the lens was formed;
FIG. 2 illustrates the various components of one embodiment of a
dehydrated soft contact lens treatment kit in accordance with this
invention; and,
FIG. 3 illustrates a convenient package arrangement for storing the
various components of a dehydrated soft contact lens treatment kit
shown in FIG. 2 .
DESCRIPTION OF THE PREFERRED EMBODIMENTS
As indicated above, the present invention contemplates a
dehydration device and kit for carrying out hydration and,
optionally, other post-lens forming operations upon a molded soft
contact lens. Illustrative of such lenses are those formed from a
lens-forming reaction mixture containing hydrophilic monomers,
e.g., those which form slightly or moderately crosslinked, three
dimensional networks as disclosed in aforesaid U.S. Pat. Nos.
2,976,576, 3,220,960 and 3,822,089. These materials upon undergoing
polymerization provide "sparingly" cross-linked, water-absorptive
shape- retaining articles such as contact lenses of 2-hydroxyethyl
methacrylate polymers. The invention contemplates lenses
manufactured from these and any other kinds of water-swellable
materials.
Following lens formation employing either of the molding procedures
referred to above, the dehydrated lens is hydrated (which also
causes the lens to separate from the mold element) and any
unreacted monomer(s) and/or other extraneous material(s) are
removed therefrom.
Referring, now, to FIG. 1, hydration device 10 includes lower and
upper members 11 and 12, respectively, which cooperate to form an
enclosure 13 of dimensions sufficient to accommodate at least one
dehydrated contact lens/mold element combination 20. Members 11 and
12 can be clear or opaque, hinged or non-hinged, i.e., detachable,
and can be provided with any suitable means to effect their
interengagement, e.g., threading, a snap-lock, friction fitting (as
shown), etc. Perforations 14a and 14b defined within lower and
upper members 11 and 12, respectively, permit passage of hydration
liquid, e.g., physiological saline, into and through enclosure 13.
As shown in FIG. 2, a portion 15 of upper member 12 can be
texturized to facilitate labelling with a pencil or indelible ink
so as to identify the combined contact lens/mold element assembly
20 enclosed in the hydration device.
While members 11 and 12 can be fabricated from a wide variety of
materials, they are preferably manufactured by injection molding a
thermoplastic resin such as polyethylene, polypropylene,
polycarbonate, polyester, polyamide, etc. The upper and lower
members of the hydration device can, if desired, be molded as a
single unit joined through a flexible hinge.
Enclosure 13 of hydration device 10 is occupied by dehydrated
contact lens 21 resident in the cavity of mold element 22. Combined
dehydrated lens/mold element assembly 20 can be provided as a
separate unit or, as illustrated, it can be provided already
present within the enclosure of hydration device 10.
In a preferred embodiment of the present invention, a quantity of
hydration devices 10 and combined dehydrated contact lens/mold
element assemblies 20 are provided in kit form together with a
quantity of hydration liquid and, if desired, one or more other
lens treating materials such as disinfectant, sterilizer, cleaner,
preservative, and the like. The individual components of one such
kit are shown in FIG. 2 and include a quantity of combined
dehydrated contact lens/mold element assemblies 20 which can be
provided in stoppered tubular containers 30a and 30b suitably
labeled to indicate the diopters of the lens and/or other lens
identifying indicia. Alternatively, the combined dehydrated contact
lens/mold element assemblies can be packaged in individually
separable and labeled bubble packets formed as part of a perforate
sheet 35 or strip. Yet another alternative is to provide combined
lens/mold assemblies 20 already contained within labelled hydration
device 10. The kit further includes a quantity of hydration liquid
40, e.g., physiological saline, which may or may not be
concentrated and which may or may not contain a buffering agent
and/or other optional ingredient(s).
Optional components of the kit can include one or more vessels 50,
preferably of flame-proof or fire-resistant glass, for holding
hydration fluid and/or other liquid(s), soft-tipped tweezers 60 for
holding the contact lenses and one or more lens treatment
materials, liquid or otherwise. Thus, e.g., the kit of this
invention can include, besides hydration liquid, one or more soft
contact lens cleaning, disinfectant, sterilizing, preserving,
storing and/or peroxide removal compositions. Examples of such
optional compositions include the oxygen-releasing salt-containing
isotonic lens cleaning and sterilizing solutions of U.S. Pat. No.
3,873,696; the nonionic surfactant-containing lens cleaning and
storing compositions of U.S. Pat. No. 3,882,036; the hydrogen
peroxide decomposition catalysts of U.S. Pat. No. 3,912,451; the
quaternary ammonium compound-containing lens sterilizing
compositions of U.S. Pat. No. 4,029,817; the
polyoxyethylene-polyoxypropylene block copolymer-containing cold
disinfectant solutions of U.S. Pat. No. 4,356,100; the
dimethyldiallylammonium chloride homopolymer-containing lens
disinfectant compositions of U.S. Pat. Nos. 4,367,548 and
4,443,429; the amphoteric surfactant, non-ionic surfactant and
chlorhexidine-containing (and, optionally, thimerosal-containing)
lens disinfecting and/or preserving solutions of U.S. Pat. No.
4,354,952; the ascorbic acid-containing ambient temperature lens
disinfectant compositions of U.S. Pat. No. 4,367,157; the
pentanedial-containing and, optionally, thimerosal-containing, lens
disinfecting and preserving solutions of U.S. Pat. Nos. 4,381,314
and 4,444,784; the lens cleaning solutions based on peroxide,
transition metal salts, amphoteric or anionic surfactants described
in U.S. Pat. No. 4,414,127; the ascorbic acid and potentiating
compound (e.g., trimethoprim or thimerosal)-containing ambient
temperature lens disinfectant solutions of U.S. Pat. No. 4,401,582;
the C.sub.5-12 fatty acid-containing disinfecting solutions of U.S.
Pat. No. 4,410,442; the mixture of surfactants employed as lens
cleaning compositions as described in U.S. Pat. No. 4,440,662; the
glycerol monolaurate and antimicrobial agent-containing lens
disinfecting compositions of U.S. Pat. No. 4,485,029; the contact
lens preserving solutions containing an ene-diol compound, e.g.,
ascorbic acid or dihydroxymaleic acid, and a source of copper ion
as disclosed in U.S. Pat. No. 4,490,389; the mixture of anionic and
nonionic surfactants, said to exhibit a synergistic lens cleaning
effect, described in U.S. Pat. No. 4,500,441; the nonionic
surfactant and chlorhexidine salt-containing lens cleaning
solutions of U.S. Pat. No. 4,504,405; the trimethoprim-containing
lens preservative compositions of U.S. Pat. Nos. 4,510,065,
4,529,535, 4,543,200 and 4,560,491 which additionally contain other
ingredients such as EDTA, benzyl alcohol and adjuvant bactericides,
e.g., sorbic acid or ascorbic acid; the lens disinfecting and
sterilizing compositions containing hydrogen peroxide, surfactant
and aqueous alcoholic mixture of a tertiary amine and a fatty acid
alkanolamide as described in U.S. Pat. Nos. 4,518,585 and
4,557,898; the sodium pyruvate-containing solutions (for
decomposing a hydrogen peroxide lens sterilizing solution)
disclosed in U.S. Pat. No. 4,521,375; the biguanide-containing lens
disinfecting and/or preserving solutions of U.S. Pat. No.
4,537,746; a neutralizer such as sodium sulfite or sodium
thiosulfate, and optionally, buffering agents, for addition to an
aqueous hydrogen peroxide lens disinfectant solution to convert the
latter into a saline lens storage solution as described in U.S.
Pat. No. 4,568,517; a catalyst such as catalase for addition to a
hydrogen peroxide lens disinfecting solution to decompose the
latter following the disinfection procedure; and, the
peroxidase-oontaining lens disinfecting system of U.S. Pat. No.
4,588,586, the disclosures of which are incorporated by reference
herein.
The necessary as well as some optional components of the contact
lens kit herein are shown in FIG. 3 assembled in a oonvenient
packaging unit 70 containing recesses for each component. Thus,
each of the kit components shown in FIG. 1 is shown occupying a
suitably dimensioned recess in packaging unit 70, e.g., fabricated
from an impact-absorbing material such as a polyolefin foam or
styrenic resin foam, which can be snugly fitted within an exterior
paper carton for shipment and/or storage.
The principal operations involving the components of the dehydrated
contact lens treatment kit of FIGS. 2 and 3 are hydration and
extraction. In the first of these operations, the combined
dehydrated soft contact lens/mold element assembly 20 is enclosed
within enclosure 13 of hydration device 10 with upper member 12
thereof being suitably marked with pencil or indelible ink to
identify the lens within. The device is then immersed in boiling
water or physiological saline for 3-5 minutes or so to hydrate lens
21 and release it from mold element 22. Following removal of the
hydration device from the boiling liquid, the mold and lens are
removed therefrom, preferably with soft-tipped tweezers 60. The
mold element is discarded and the lens is returned to cavity 13 of
hydration device 10 for the extraction procedure. In the latter
operation, water or saline 40 is heated to 60 .+-.10.degree.C. and
the hydration device with its hydrated lens is immersed therein for
four hours. Thereafter, the lens is placed in vessel 50 containing
a small quantity of saline 40 for about one hour. The hydrated,
extracted lens may thereafter be washed, sterilized, etc., prior to
being worn.
Although illustrative embodiments of the present invention have
been described herein with reference to the accompanying drawings,
it is to be understood that the invention is not limited to these
precise embodiments, and that various other changes and
modifications may be effected therein by one skilled in the art
without departing from the scope or spirit of the invention.
* * * * *